Will NuvaRing Safety Study Findings Be Addressed By FDA Advisory Committees At Joint Meeting In December 2011?
On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the NuvaRing (etonogestrel / estradiol vaginal ring) -- referred to as "ETON" in this 2011 FDA study report.
This FDA study was intended to determine whether the NuvaRing -- as well as some other relatively new birth control products, namely the Ortho Evra patch and all DRSP-containing oral contraceptives like YAZ, Yasmin, Ocella, etc. -- was associated with an increased risk of cardiovascular side effects such as:
- Venous thromboembolic events (VTE), including deep venous / vein thrombosis (DVT) and pulmonary embolism (PE); and,
- Arterial thrombotic events (ATE), including heart attack / acute myocardial infarction (AMI), and ischemic stroke.
In relevant part, this new FDA study found that the NuvaRing was associated with a significantly higher risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) relative to standard low-dose estrogen birth control pills, with the estimate of relative risk for NuvaRing being 1.56 (95% CI 1.02 to 2.37).
One of the key points made in this October 2011 FDA study report is that continuous exposure combined hormonal contraceptives such as the NuvaRing "potentially result in higher sustained exposure to estrogen and hence, increased thromboembolic risk".
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Here are the reasons this FDA birth control safety study, which includes NuvaRing, was done:
The objective of the FDA-funded study was to assess cardiovascular risks, including the risk of thrombotic and thromboembolic events and death, for several newly approved (early 2000s) products that had sufficient numbers of users to allow for an evaluation of these risks compared to those associated with use of older, more frequently prescribed contraceptives at the sites selected. If an increased risk was observed, the FDA-funded study would subsequently attempt to assess user characteristics and prescribing patterns that might help explain the increased risk. It was recognized at the time that a more in-depth assessment of potential reasons for increased risk would not be possible using only claims and electronic medical records and would require physician and patient contact, something that could be conducted later if needed. [emphasis added]
One hopes that those new study findings about NuvaRing side effects -- like PE and DVT, as well as strokes and heart attacks -- are presented by the FDA to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting which will take place December 8 - December 9, 2011 in the Washington, DC area.
Of course, we will be watching for any continuation of this FDA NuvaRing safety study -- as the agency's explanation of its reasons for this birth control study, above, suggests is a possibility.
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